Hepatitis C: Completing the Diagnosis with HCV RNA Testing October - - PowerPoint PPT Presentation

• Analysis. Answers. Action.

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Hepatitis C: Completing the Diagnosis with HCV RNA Testing

October 22, 2019 | 3-4 pm ET Welcome

Carolyn Wester, MD, MPH Director of the Division of Viral Hepatitis (DVH) Speakers

Lindsay Jolly MPH, CPH, MLS (ASCP) Tennessee Department of Health Liisa Randall, PhD and Glen Gallagher, MLS(ASCP)CM, PhD Massachusetts Department of Public Health

• Analysis. Answers. Action.

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Hepatitis C: Completing the Diagnosis with HCV RNA Testing

The Association of Public Health Laboratories adheres to established standards regarding industry support of continuing education for healthcare professionals. The following disclosures of personal financial relationships with commercial interests within the last 12 months as relative to this presentation have been made by the speaker(s): Nothing to Disclose

• Analysis. Answers. Action.

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Hepatitis C: Completing the Diagnosis with HCV RNA Testing

Speaker

Lindsay Jolly MPH, CPH, MLS (ASCP) Immunoserology Supervisor, Division of Laboratory Services, Tennessee Department of Health

Hepatiti Hepatitis C: s C: Complet Completin ing the g the Diagnosi Diagnosis s with HCV RNA Testing with HCV RNA Testing

A Tale from Tennessee

Linds dsay Jolly, MPH PH, CPH, CPH, MLS S (ASC ASCP)CM

CM | O

Octobe ber 22, 22, 20 2019

Facu culty ty D Disc sclo losu sure

• Lindsay Jolly, MPH, CPH, MLS (ASCP)CM |

October 22, 2019

• A Tale from Tennessee

Objectives Objectives

• Describe the HCV testing algorithm
• Discuss how HCV RNA testing was implemented at the Tennessee

Department of Health, Laboratory Services Division

• Demonstrate the effectiveness of collaboration between the PHL and
• ther public health entities

CDC CDC Testing Algorithm Testing Algorithm

HCV HCV in Tennessee in Tennessee- A history A history

• CDC identified 41 counties in TN

as vulnerable regions in their 2015 Vulnerability Assessment

• This assessment indicated that

20% of Tennessee’s population was at risk for an HIV/HCV

• utbreak.
• HCV cases in TN were rising in

parallel with opioid addiction

Reported Reported Cases of Acute Cases of Acute HCV in HCV in Tennessee Tennessee

2013 2014 2015 2016 2017 US Case rate 0.7 0.7 0.8 1.0 1.0 Cases 2,138 2,194 2,436 2,967 3,186 TN Case rate 1.5 1.9 2.6 2.3 2.1 Cases 98 123 173 150 142 Rank 6th 5th 4th 6th 6th

Sources: Table: CDC 2017 Viral Hepatitis Surveillance – United States Map: TDH Viral Hepatitis 2018 Frozen Dataset

Planning Phase Planning Phase

• Regular meetings between the Viral Hepatitis (VH) program and TDHLS
• TDHLS researched available HCV testing platforms for both screening and

confirmatory assays

– Goal was to complete the entire algorithm in-house

• CDC Supplemental Funding awarded to the VH program in April 2016

– Planned the pilot study for eastern TN

• Informatics Team brought in to work on assay development in LIMS

Pilot Study Pilot Study

• Included 3 major Health Departments (HD)

– Primarily STD and FP clinics

• Specimens were collected over a 5 month period
• Lots of considerations

– Specimen collection and handling – Risk factor assessment – Post-test counseling and referral to care – Training for HD staff – Reporting of patient results – Staffing requirements

Total Total Study Population Study Population

• During June 1–October 31, 2016:

4,753

Patients were tested for HCV

Slide credit: TDH Viral Hepatitis Program

Ongoing Testing Ongoing Testing

• Pilot was successful
• VHP decided to rollout HCV testing statewide

– Regions were added in phases – Substance Abuse Pilot-HIV, HBV, HCV – TN Dept of Corrections

• Due to increased testing volumes, DLS transitioned from manual HCV NAT

to the automated HCV RNA assay on the Hologic Panther.

• Validated the HCV Quant Dx for qualitative use.

Funding Funding

Lessons Learned Lessons Learned

• Collaboration is essential

– TDH Division of Laboratory Services

• Laboratory Staff
• Informatics Team

– Tennessee Viral Hepatitis Program – Regional and Local Health Departments – Community Based Organizations

• Lab should anticipate the needs of the programs
• Learn from past experiences
• Start small

Thank you! Thank you!

• Analysis. Answers. Action.

www.aphl.org

Hepatitis C: Completing the Diagnosis with HCV RNA Testing

Speakers

Liisa Randall, PhD Director, Office of Health Care Planning, Massachusetts Department of Public Health Glen Gallagher, MLS(ASCP)CM, PhD Division Director of Molecular Diagnostics and Virology, Massachusetts Public Health Laboratory

Strengthening Testing and Linkage for Hepatitis C in Massachusetts

Liisa M. Randall, PhD Director, Office of Health Care Planning Glen Gallagher, PhD Director, Molecular Diagnostics and Virology

Hepatitis C: Completing the Diagnosis with HCV RNA Testing October 22, 2019

Massachusetts Department of Public Health Bureau of Infectious Disease and Laboratory Sciences

Context & Goals

• Program
• Public Health Laboratory
• Surveillance

Enabling Environment

• Administration

– Bureau organization – Integrated procurement, contract management, and capacity building

• Operation

– Specimen submission to SPHL – Co-testing – Reflex testing

• Policy

– State appropriations

• 3rd party billing
• Retained revenue

– Universal coverage

• No treatment restrictions

– Opioid response

Confirmed and Probable HCV Cases by Year and Age Group, Massachusetts, 2007-2018

Data source: Massachusetts Department of Public Health, Bureau of Infectious Disease and Laboratory Sciences.

Data current as of 3/25/19 and are subject to change

HCV Laboratory Testing Cascade: Massachusetts 2014-2016

Vo, Quynh, et al. “The Massachusetts Hepatitis C Testing Cascade, 2014-2016.” Microbiology Insights, vol. 12, 21 June 2019, pp. 1-6.

Integrated HIV/HCV/STI/TB Testing Programs

48 partner agencies 120+ locations CBOS CHCs Hospitals DOC HOCs SSPs SUD/OTP Mobile

MA SPHL

25

Syringe Services Programs

https://www.mass.gov/info-details/syringe-service-program-locator

as of September 2019, n=33

HIV/HCV/Syphilis Testing Volume, MA SPHL 2013 – 2019

Automated Ab HIV/HCV co-testing (April) Discontinue HIV RT (October) HCV Reflex (July)

Data Source: BIDLS/MDPH. Current as of 10/17/19

HCV Infections Identified, MA SPHL 2013 – 2019

Data Source: BIDLS/MDPH. Current as of 10/17/19

HIV/HCV co-testing (April) HCV Reflex (July)

Outcomes

• Uptake of HCV testing

– 228% increase in HCV test volume - 2013 and 2018 – PWID

• 637% increase in HCV test volume - 2013 and 2018
• 19% of all tests; 77% HCV+ in 2019 YTD

– Project approximately 38,000 HCV tests in 2019

• Identification of Infection

– 776 % Increase in HCV+ btw 2013 and 2018 – With reflex 12% HCV+ – 19% are new diagnoses

Data Source: BIDLS/MDPH. Current as of 10/17/19

Coordinated Approach to HCV NAAT Implementation

HCV NAAT

Lab Epi

Program

Lab Capacity Evaluation Test Choice Test Implementation

Lab Capacity Evaluation

• Current testing infrastructure will

guide decisions for implementation

HCV NAAT

No HCV NAAT Manual HCV NAAT Automated HCV NAAT

POC Rapid test chemiluminescent microparticle immunoassay (CMIA) HCV Antibody HCV RNA

Lab Capacity Evaluation

• Current lab structure

– Available equipment – Space requirements – Personnel – Testing schedule

• Multiple Procurement options

– Instrument purchase – Reagent rental agreement – Lease

HCV NAAT

Budget

Test Choice

Evaluation of current testing system and available test platforms – Patient population served

• Prevalence and risk
• Platform performance sensitivity/ specificity

– Sample types

• Serum vs Plasma

– Processing requirements

• Centrifugation timing

– Shipping

• Current logistics structure (ambient vs frozen)
• Package insert requirements
• May need sample stability study

HCV NAAT

Test Implementation

HCV NAAT

Component Responsible Parties Considerations Method comparison or verification study Lab Administration

• New instruments
• New testing method

Personnel training, competency, proficiency testing Lab administration

• Previous experience

with molecular techniques

• Environmental

monitoring Reporting CLIA or Lab Directors / IT /Surveillance

• Reporting to labs
• Reporting to

epidemiologists Messaging and training providers Program / Lab Administration /Surveillance

• Sample collection and

shipping

• Results interpretation

Messaging to Clinicians Program / Lab Administration/ Surveillance

• Clinical management

guidance

• Results interpretation

Future

• Further expansion with SSP, opioid

prevention investments

• Data-driven enhancements

– Targeting to address gaps in access/uptake – Focused capacity building on LTC – Laboratory, provider capacity

• Ongoing submitter education/TA

Thanks for Joining! For any questions contact Anne.Gaynor@aphl.org